HomeChinaHuaiyin Medical Instruments Co.,Ltd

Huaiyin Medical Instruments Co.,Ltd

China · 淮安 · www.hy-medical.com
✓ Record-verifiedregistrations found in 10 marketsEU SRN CN-MF-000003351Unified social credit code 91320800139432406U

This company holds 88 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Saudi Arabia, South Korea, Australia, Israel, Russia — 9 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
88China registrations
Class I 77Class II 9Class III 2
as of 2026-09-04
EUEuropean UnionEUDAMED
149UDI-DI device records
Class IIa 22Class IIb 95Class III 32
USUnited StatesFDA openFDA
1listed device types
Class I 1Class II 0Class III 0
plus 1 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
15registered device records
Class IIa 3Class IIb 10Class III 2
BRBrazilANVISA
12registered devices
Class I 1Class II 11
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
1registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
0valid device licences
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
2GMP quality-system certificates
Import 2
AUAustraliaTGA ARTG
11active ARTG entries
Class I 7Class III 1IIa 2IIb 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
2registrations
RURussiaRoszdravnadzor
5active registrations
Class 1 1Class 2a 2Class 2b 1Class 3 1
Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

European Union149 raw hits, 0 excluded, 149 confirmed
United States1 registration records, 0 510(k), 0 PMA
China88 certificates (Class III 2 / II 9 / I 77), as of 2026-09-04
United Kingdom15 confirmed, 0 excluded
Brazil12 confirmed, 0 excluded
Saudi Arabia1 confirmed, 0 excluded
Manufacturer names merged into this page: HUAIYIN MEDICAL INSTRUMENTS CO., LTD. · HUAIYIN MEDICAL INSTRUMENTS CO LTDA · HUAIYIN MEDICAL INSTRUMENTS CO., LTD · HUAIYIN MEDICAL INSTRUMENTS CO. LTD. · Huaiyin Medical Instruments Co,Ltd

Regulatory identity

EU manufacturer SRN
CN-MF-000003351
EU authorised representative
Wellkang Ltd
UK responsible person
Wellkang Ltd
Unified social credit code
91320800139432406U
Exhibition record
CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
450
Annual revenue
RMB 100–500M
Website
www.hy-medical.com
Product categories
手术室及急救

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

Business registration

Registration status
Active
Incorporated
1999-06-07
Registered capital
CNY 22,269,830
Paid-in capital
CNY 10,000,000
Legal form
Limited liability company (wholly owned by a natural-person-controlled corporation)
Industry classification
Pharmaceutical manufacturing
Last approval date
2026-06-01
Recognitions
National High-Tech EnterpriseSRDI SME

Business registration data from Tianyancha, as of 2026-09-02. Public registry information only; legal representative and contact-person details are not collected. The figure is the number of employees enrolled in social insurance as declared by the company, which may differ from actual headcount.

FDA listed device types

Blade, Scalpel 1

Registration details (sample)

MarketIdentifierNameClass / date
CN国械注准20263020252可吸收性外科缝线Class III
CN国械注准20173024723可吸收性外科缝线Class III
CN苏械注准20242022036非吸收性聚酰胺缝合线Class II
CN苏械注准20202170664一次性使用无菌牙科刀Class II
EU16937276003354Class IIb
EU16938535506418Class III
EU16938535506197Class III
EU16938535506005Class III
UK13904Sterile Non-Absorbable Surgical Sutures with/without needles -Stainless steel wire sutureClass IIb
UK38000Non-absorbable Surgical Suture With/Without Needle-Nylon SutureClass IIb
UK37997Sterile Non-Absorbable Surgical Sutures with/without needles -Nylon sutureClass IIb
BR10150470194LANCETA PICADORA WILTEXClass I
BR80679519012FIO DE SUTURA EM SEDA PRETOClass II
BR80679519013FIO DE SUTURA EM NYLON MONOFILAMENTO PRETOClass II
SAME0000004809SFDAA00001MEIYI Disposable Scalpels with plastic handle

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